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Biologics Naming: WHO Final Plan, FDA Draft Guidance Incompatible

 
• By Sue Sutter

US regulator could try to harmonize its nonproprietary naming approach with World Health Organization's biological qualifier system or stick with its suffix-based proposal; while having different names across the globe for a single product is not ideal, it's also not an insurmountable problem, experts say.

With the World Health Organization having finalized a voluntary naming convention for biologics, the focus now turns to whether FDA will stick with its own proposed nomenclature approach or adopt the WHO model.

Although there are similarities between WHO's final plan and FDA's naming system, which remains in draft form, there are important...

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